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A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804

Last updated on August 9, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male subjects and/or healthy female subjects of non-child bearing potential
between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically
relevant abnormalities identified by a detailed medical history, full physical
examination, including blood pressure and pulse rate measurements, 12-lead ECG and
clinical laboratory tests.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110
lbs).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- A positive urine drug screen.

- History of regular alcohol consumption exceeding 14 drinks/week for males.

NCT01924650
Pfizer
Withdrawn
A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804

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A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804
A Randomized, Open Label, Single Dose, 6 Treatment, 4-way Crossover Study in Healthy Subjects to Assess the Pharmacokinetics of Three Different Particle Sizes of PH-797804 Tablet With and Without the Solubilizing Agent Sodium Lauryl Sulphate (SLS)
The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
Drug: PH-797804
Tablet, 6 mg, single dose
  • Experimental: PH-797804 PARTICLE SIZE 9-11UM
    Intervention: Drug: PH-797804
  • Experimental: PH-797804 PARTICLE SIZE 9-11UM WITH SLS
    Intervention: Drug: PH-797804
  • Experimental: PH-797804 PARTICLE SIZE <= 20UM
    Intervention: Drug: PH-797804
  • Experimental: PH-797804 PARTICLE SIZE <= 20UM WITH SLS
    Intervention: Drug: PH-797804
  • Experimental: PH-797804 PARTICLE SIZE <= 5UM
    Intervention: Drug: PH-797804
  • Experimental: PH-797804 PARTICLE SIZE <= 5UM WITH SLS
    Intervention: Drug: PH-797804
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2014
June 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 14 drinks/week for males.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01924650
A6631040
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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